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Rheumatology Diagnostic Laboratory (RDL)

Contacts
To order tests, or for more information:
Barbara Rao, RDL Customer Service
(800) 338-1918

For technical information:
Erik Avaniss-Aghajani, Ph.D.
(800) 338-1918
erik@laragen.com

www.rdlinc.com


GENERAL INFORMATION

Assay Names Genotype ViroSeq™ HIV-1 Genotyping System (Applied Biosystems)

TruGene™ HIV (Visible Genetics)

[RDL test name = "Virotype"]
Collaborators/Distributors Applied Biosystems, Visible Genetics
Availability Commercially available for research use only.
Regulatory Status
ViroSeq™ HIV-1 and TruGene™ HIV are approved for "Investigational Use Only" under an FDA-approved IDE in CLIA certified labs. RDL is a CLIA-approved laboratory.
Proficiency Testing Programs Content in development.
Clinical Trials No
Financial Assistance Approved Provider, California Department of Health, Office of AIDS HIV Resistance Testing Program.


ASSAY INFORMATION

Genotypic Codons Interrogated
ViroSeq TruGene RT PI
Full sequence Full sequence 1–320 (ViroSeq)
40–247 (TruGene)
1–99

Turnaround Time Sensitivity
ViroSeq TruGene ViroSeq TruGene
10 days 7–14 days 500 RNA copies/mL 1,000 RNA copies/mL


METHODOLOGY

Genotype
RDL primarily uses the Applied Biosystems (formerly PE Biosystems) ViroSeq™ HIV-1 Genotyping System. Failed samples are re-run with the Visible Genetics TruGene™ HIV test.


REPORT INFORMATION

Report Drug Resistance Interpretation
Genotype Yes Interpretation provided by request by the Stanford HIV RT and Protease Sequence Database Sequence Analyzer (beta test version)


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